FDA Update: Agency Recalls Dabigatran Etexilate Capsules Due to NDMA Impurity

The U.S. Food and Drug Administration (FDA) announced a nationwide recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, by Ascend Laboratories LLC due to detection of N-Nitrosodimethylamine (NDMA) impurity.

The presence of a nitrosamine (n-nitroso-dabigatran) above the Acceptable Daily Intake level was identified in product, used as an oral anticoagulant. There have been no reports of adverse events related to the recall at this time.

For more information and agency recommendations, access the FDA website

Clinical Topics: Anticoagulation Management, Novel Agents

Keywords: Capsules, Anticoagulants, Laboratories, Nitrosamines, United States Food and Drug Administration, No-Observed-Adverse-Effect Level, Dimethylnitrosamine, Dabigatran, ACC Advocacy

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